North America

Humacyte's bioengineered vessel delivered 91 more catheter-free days than standard-of-care AV fistula in female dialysis patients, triggering a supplemental BLA filing.

The GPER agonist joins the NIA's Interventions Testing Programme, complementing a separate $22m ARPA-H contract to evaluate healthspan preservation.

RadioMedix's generic gallium-68 PSMA-11 PET diagnostic for prostate cancer has received FDA approval, with the Houston facility clearing inspection with no observations.

Rafael Holdings has reached last-patient-last-visit in its 94-patient TransportNPC trial, with topline data and an NDA submission both expected in H2

Teva paid $700 million upfront for Emalex Biosciences, acquiring a Phase 3-complete D1 antagonist with an NDA filing expected in the second half of

The New Jersey biotech's once-nightly, low-sodium oxybate candidate secured ODD based on its potential to eliminate the disruptive mid-night second dose.

Alterity's End-of-Phase 2 meeting secured FDA agreement on trial design, dosing, and endpoints for its pivotal ATH434 programme in multiple system atrophy.

The Cambridge biotech can now advance directly into a randomised Phase 1/2 study of its oral AKT1 inhibitor in hereditary haemorrhagic telangiectasia.

The Paris-based biotech secured RMAT status for its CD22-targeting off-the-shelf CAR-T candidate in relapsed or refractory B-cell acute lymphoblastic

A peer-reviewed study in Critical Care Medicine found Ceribell's AI algorithm associates high seizure burden with a 3.4-fold rise in death

Health Canada has accepted Chiesi's birch triterpenes gel for priority review, potentially making it the first therapy approved for EB wounds in Canada.

Disc Medicine said a Type A FDA meeting confirmed the Phase 3 APOLLO study could support a traditional approval for bitopertin in EPP, with data

CTA313 targets CD19 and BCMA in a Phase 1b basket trial spanning lupus, progressive MS, and autoimmune encephalitis.

KT-485's Phase 1 first-in-human start triggers a $20m milestone payment from Sanofi under their IRAK4 degrader collaboration.

Subcutaneous BRIUMVI hit MCID in 82% of myasthenia gravis patients at Week 24, prompting a potentially registration-directed Phase 2 sequential-therapy trial.

The Basel biotech has initiated SIRIUS, a Phase 2 COPD trial of its twice-yearly anti-TSLP antibody WIN378, alongside an ongoing asthma programme.

The Iceland-based biosimilar specialist said the FDA has accepted its BLA for AVT16, a proposed interchangeable biosimilar to Takeda's Entyvio, for ulcerative colitis

Artiva Biotherapeutics secured RMAT designation for its allogeneic NK cell therapy after Phase 2a data showed durable responses in refractory rheumatoid arthritis.

All 12 patients in a UChicago Medicine pilot achieved insulin independence, with mean HbA1c of 5.4% and no severe hypoglycaemic episodes post-transplant.

GI prophylaxis cut Grade 2+ diarrhoea and colitis from 55% to 10% in the GCC-targeted CAR T-cell trial for metastatic colorectal cancer.